21 CFR 888.1600 — Bone Indentation Device
Orthopedic (OR) · Part 888 Subpart B—Diagnostic Devices · § 888.1600
Identification
A bone indentation device is a device that measures resistance to indentation in bone.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QGQ | Bone Indentation Device | 2 | 3 |
Special Controls
QGQ — Bone Indentation Device
In combination with the general controls of the FD&C Act, the bone indentation device is subject to the following special controls: - (1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate the risk of bone fracture, soft tissue damage, pain, discomfort, bruising, or bleeding. - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of the accuracy and precision of the device with respect to resistance to bone indentation. - (3) Human factors testing must demonstrate that the intended user(s) can correctly use the device, based on the instructions for use. - The patient-contacting components of the device must be demonstrated to be (4) biocompatible. - (ર) Performance testing must demonstrate: - The sterility of the patient-contacting components of the device; and (i) - (ii) Validation of reprocessing instructions for any reusable components of the device. - Performance data must support the shelf life of the device by demonstrating continued (6) sterility and device functionality over the identified shelf life. - Software verification, validation, and hazard analysis must be performed. (7) - (8) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. - (9) Labeling must include: - (i) Instructions for use: - (ii) Validated methods and instructions for reprocessing of any reusable components; - (iii) A shelf life for any sterile components; - (iv) Information regarding limitations of the clinical significance of the device output; and - A detailed summary of the accuracy and precision of the device. (v)
De Novo Order DEN210013
QGQ — Bone Indentation Device
*Classification.* Class II (special controls). The special controls for this device are:(1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate the risk of bone fracture, soft tissue damage, pain, discomfort, bruising, or bleeding. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of the accuracy and precision of the device with respect to resistance to bone indentation. (3) Human factors testing must demonstrate that the intended user(s) can correctly use the device, based on the instructions for use. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Performance testing must demonstrate: (i) The sterility of the patient-contacting components of the device; and (ii) Validation of reprocessing instructions for any reusable components of the device. (6) Performance data must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life. (7) Software verification, validation, and hazard analysis must be performed. (8) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. (9) Labeling must include: (i) Instructions for use; (ii) Validated methods and instructions for reprocessing of any reusable components; (iii) A shelf life for any sterile components; (iv) Information regarding limitations of the clinical significance of the device output; and (v) A detailed summary of the accuracy and precision of the device.
eCFR
QGQ — Bone Indentation Device
(1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate the risk of bone fracture, soft tissue damage, pain, discomfort, bruising, or bleeding. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of the accuracy and precision of the device with respect to resistance to bone indentation. (3) Human factors testing must demonstrate that the intended user(s) can correctly use the device, based on the instructions for use. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Performance testing must demonstrate: (i) The sterility of the patient-contacting components of the device; and (ii) Validation of reprocessing instructions for any reusable components of the device. (6) Performance data must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life. (7) Software verification, validation, and hazard analysis must be performed. (8) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. (9) Labeling must include: (i) Instructions for use; (ii) Validated methods and instructions for reprocessing of any reusable components; (iii) A shelf life for any sterile components; (iv) Information regarding limitations of the clinical significance of the device output; and (v) A detailed summary of the accuracy and precision of the device.
Ecfr Llm
